Class 2 Device Recall Micromax Anchors,

• Date Initiated by Firm: January 25, 2012
• Date Posted: March 21, 2012
• Recall Status: Terminated on April 12, 2013
• Recall Number: Z-1232-2012
• Recall Event ID: 61104
• 510(K)Number: K080088
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
• Code Information: 40370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 83271040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 37793040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications, Contraindications, Possible Adverse Effects, and some Warnings are not present with the packaged device.
• FDA Determined Cause: Packaging
• Action: Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST)
• Quantity in Commerce: 1414
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC